FDA clearance requires health tech devices and companies to go through months and years of clinical trials and documentation, but in the tech industry, where “move fast and break things” is the mantra, the FDA could be moving too slow.
This has caused companies that are developing emerging health tech to take two options — the first is going through the long clearance process; the second is avoiding the FDA weigh-in altogether.
This second approach requires companies to take the “wellness” route.
Consumer health gadgets focused on wellness features like step counts, activity tracking and sleep monitoring don’t require FDA review. And for features that straddle the line between wellness and medicine, companies will often make sure they fall on the wellness side in order to avoid the FDA hurdles, meaning the data is meant for entertainment only and makes no promises of clinical accuracy.
But according to the article, FDA clearance may also be the only way a company can get certain novel health tech into the hands of consumers, and if companies really want their devices on the market, they can’t keep hiding behind the wellness label.
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